Apparatus for inserting a surgical device at least partially through a wound opening

ABSTRACT

An apparatus ( 1 ) for inserting a wound retractor device ( 2 ) at least partially through a wound opening. The apparatus ( 1 ) comprises a conveying device ( 4 ) and a holder element ( 5 ). The conveying device ( 4 ) is insertable at least partially through the wound opening to convey the would retractor device ( 2 ) at least partially through the wound opening. The holder element ( 5 ) holds part of the wound retractor device ( 2 ) in a low-profile configuration. The holder element ( 5 ) is slidable relative to the conveying device ( 4 ) between a holding configuration in which part of the wound retractor device ( 2 ) is held in the low-profile configuration, and a release configuration in which the wound retractor device ( 2 ) is released. As the conveying device ( 4 ) is inserted through the wound opening, the holder element ( 5 ) engages with the external surface of the tissue. In this manner the holder element ( 5 ) is moved from the holding configuration to the release configuration.

INTRODUCTION

This invention relates to an apparatus for inserting a surgical deviceat least partially through a wound opening, to a method of inserting thesurgical device at least partially through the wound opening, and to anopening device to create a wound opening.

STATEMENTS OF INVENTION

According to the invention there is provided an apparatus for insertinga surgical device at least partially through a wound opening, theapparatus comprising:—

a conveying device insertable at least partially through a wound openingto convey a surgical device at least partially through the woundopening; anda holder element for holding at least part of the surgical device in alow-profile configuration.

It has been found that the apparatus according to the invention resultsin particularly low profile insertion of the surgical device. The holderelement facilitates ease of insertion of the surgical device, whileminimising trauma to the sides of the wound opening. In addition theprocess of insertion of the surgical device using the apparatusaccording to the invention is a particularly simple process with aminimum number of stages required by the user.

In one embodiment of the invention the holder element is configured tobe disassembled from the conveying device. The holder element may beconfigured to be disassembled from the conveying device after conveyingof a surgical device at least partially through a wound opening. Theholder element may be configured to be disassembled from a surgicaldevice. The holder element may comprise a circumferential discontinuity.The circumferential discontinuity facilitates disassembly of the holderelement from the surgical device.

In one embodiment of the invention the holder element is movablerelative to the conveying device between a holding configuration inwhich at least part of a surgical device is held in a low-profileconfiguration, and a release configuration in which the surgical deviceis released. The holder element may be slidable relative to theconveying device between the holding configuration and the releaseconfiguration. The holder element may be slidable relative to theconveying device along the conveying device. The holder element may beengagable with an external surface of tissue upon insertion of theconveying device at least partially through a wound opening to move theholder element from the holding configuration to a releaseconfiguration. The holder element may be movable radially relative tothe conveying device between the holding configuration and the releaseconfiguration. The holder element may be configured to be arrangedconcentrically around the conveying device at least in the holdingconfiguration. The holder element may be removable from beingconcentrically around the conveying device.

The holder element may be configured to be arranged radially offset fromthe conveying device at least in the holding configuration.

In one embodiment the holder element is movable relative to theconveying device between a storage configuration in which at least partof a surgical device is released, and the holding configuration. Becausethe surgical device is released in the storage configuration, thisenables the surgical device to be stored for relatively long periods oftime without damaging or degrading the surgical device. The holderelement may be slidable relative to the conveying device between thestorage configuration and the holding configuration. The holder elementmay be configured to be arranged concentrically around at least part ofa surgical device in the storage configuration. The holder element maycomprise one or more openings through which part of a surgical devicemay extend in the storage configuration.

The holder element may be configured to extend radially outwardly fromthe conveying device. In one case the holder element comprises anannular flange element. In another case the holder element comprises atubular element.

In one embodiment the holder element is configured to assist collapse ofat least part of a surgical device from a release configuration to alow-profile configuration. At least part of the holder element maycomprise a funnel part. At least part of the holder element may betapered. At least part of the holder element may taper radially inwardlydistally.

The holder element may be non-circular in cross-section. The holderelement may be elliptical in cross-section.

The holder element may be configured to be attached to a surgicaldevice.

In one case the conveying device comprises a retaining element to retaina surgical device in engagement with the conveying device, and apassageway to facilitate location of the surgical device in engagementwith the conveying device, the retaining element being configured toselectively obstruct the full width of the passageway. The proximal endof the retaining element may be located proximally of the proximal sideof the passageway. The distal end of the retaining element may belocated distally of the distal side of the passageway. The retainingelement may overlap the passageway.

In another embodiment the conveying device comprises a hook element toengage a surgical device. The hook element may be non-symmetrical incross-section. The hook element may be non-circular in cross-section.

In a further embodiment the apparatus comprises an opening device tocreate a wound opening. The opening device may be configured to create awound opening by forcing tissue apart. The opening device may be mountedto the conveying device. The opening device may be non-symmetrical incross-section. The major axis of the opening device may be substantiallyaligned with the major axis of the hook element. By aligning the majoraxes, this arrangement minimises the profile of the apparatus and thesurgical device, and minimises the trauma on the tissue surrounding thewound.

In another aspect of the invention there is provided a surgical assemblycomprising:—

a surgical device; andan apparatus of the invention for inserting the surgical device at leastpartially through a wound opening.

In one embodiment of the invention the surgical device comprises a woundretractor device. The wound retractor device may comprise a distalmember for location internally of a wound opening to anchor the woundretractor device in position retracting the wound opening.

The assembly may comprise a pack for the surgical device and theapparatus. The holder element may be movable relative to the conveyingdevice in the pack between the storage configuration and the holdingconfiguration.

In another aspect the invention provides an opening device to create awound opening, the size of at least part of the opening device beingadjustable to vary the size of the wound opening created.

In one embodiment of the invention the lateral dimension of the openingdevice is adjustable. The width of the opening device may be adjustable.

In one embodiment of the invention the opening device comprises a distalhead, the size of the distal head being adjustable.

In one case the opening device is configured to create a wound openingby forcing tissue apart. At least part of the opening device may benon-symmetrical in cross-section. The size of at least part of theopening device may be adjustable in a direction parallel to the majoraxis of the opening device.

In another embodiment the device comprises one or more wing elements.The wing element may be movable relative to a main body portion of thedevice between a narrowed configuration and a widened configuration.

In another case the device comprises an actuator to control adjustmentof the size of at least part of the opening device.

The invention also provides in a further aspect an apparatus forinserting a surgical device at least partially through a wound opening,the apparatus comprising:—

a conveying device insertable at least partially through a wound openingto convey a surgical device at least partially through the woundopening; andan opening device of the invention.

According to another aspect of the invention there is provided anapparatus for inserting a surgical device at least partially through awound opening, the apparatus comprising:—

a conveying device insertable at least partially through a wound openingto convey a surgical device at least partially through the woundopening; anda handle for gripping the apparatus; the handle being radially offsetfrom the longitudinal axis of the conveying device.

In one embodiment of the invention the conveying device has a lumenextending at least partially therethrough, through which a laparoscopemay extend. Because the handle is radially offset, this arrangementfacilitates ease of passage of the laparoscope through the lumen. Thelumen may extend parallel to the longitudinal axis of the conveyingdevice. The lumen may extend in-line with the longitudinal axis of theconveying device. The apparatus may be asymmetrical about thelongitudinal axis of the conveying device.

The invention also provides in a further aspect a method of inserting asurgical device at least partially through a wound opening, the methodcomprising the steps of: —

providing a surgical device;creating a wound opening;holding at least part of the surgical device in a low-profileconfiguration; andconveying the surgical device at least partially through the woundopening.

In one embodiment of the invention the surgical device is conveyed atleast partially through the wound opening using a conveying device, andthe surgical device is held in the low-profile configuration using aholder element. The holder element may be disassembled from theconveying device. The holder element may be disassembled from thesurgical device.

In one embodiment of the invention the method comprises the step ofreleasing the surgical device. The method may comprise the step ofcollapsing at least part of the surgical device to the low-profileconfiguration before conveying at least partially through the woundopening. The holder element may remain externally of the wound opening.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will be more clearly understood from the followingdescription of some embodiments thereof, given by way of example only,with reference to the accompanying drawings, in which:—

FIG. 1 is an isometric view of a conveying device of an apparatusaccording to the invention;

FIG. 2 is an enlarged, isometric view of a part of the conveying deviceof FIG. 1;

FIG. 3 is an isometric view of the apparatus according to the inventionand a surgical device;

FIGS. 4 to 7 are isometric views of the apparatus and the surgicaldevice of FIG. 3, in use;

FIGS. 8 and 9 are cross-sectional, side views of the surgical device ofFIG. 3, in use;

FIGS. 10 and 11 are isometric views of the apparatus and the surgicaldevice of FIG. 3, in use;

FIG. 12 is an isometric view of another apparatus according to theinvention and a surgical device;

FIG. 13 is an isometric view of the apparatus and the surgical device ofFIG. 12, in use;

FIG. 14 is an isometric view of a further apparatus according to theinvention and a surgical device;

FIGS. 15 and 16 are isometric views of the apparatus and the surgicaldevice of FIG. 14, in use;

FIG. 16( a) is an isometric view of a holder element of anotherapparatus according to the invention;

FIG. 16( b) is a plan view of the holder element of FIG. 16( a);

FIGS. 16( c) and 16(d) are isometric views of the apparatus according tothe invention and a surgical device, in use;

FIG. 16( d)(i) is a plan view from above of the apparatus and thesurgical device of FIGS. 16( c) and 16(d) in a storage configuration ina pack;

FIG. 16( d)(ii) is a plan view from below of the apparatus and thesurgical device of FIG. 16( d)(i) in the storage configuration in thepack;

FIG. 16( d)(iii) is a plan view from above of the apparatus and thesurgical device of FIG. 16( d)(i) in a holding configuration in thepack;

FIG. 16( e) is an isometric view of a holder element of anotherapparatus according to the invention;

FIG. 16( f) is a side view of the holder element of FIG. 16( e);

FIG. 16( g) is a plan view of the holder element of FIG. 16( e);

FIG. 16( h) is an isometric view of a holder element of a furtherapparatus according to the invention and a surgical device;

FIGS. 16( i) to 16(n) are isometric views of another apparatus accordingto the invention and a surgical device, in use;

FIG. 16( o) is an isometric view of a holder element of anotherapparatus according to the invention;

FIG. 16( p) is an isometric view of the holder element of FIG. 16( o)and a surgical device;

FIGS. 16( q) to 16(t) are isometric views of the apparatus according tothe invention and the surgical device of FIG. 6( p), in use;

FIG. 17 is an isometric view of the conveying device of FIG. 1, in use;

FIG. 18 is a view similar to FIG. 1 of a conveying device of anotherapparatus according to the invention;

FIG. 19 is a side view of another apparatus according to the inventionin a narrowed configuration;

FIG. 20 is an end view of the apparatus of FIG. 19 in the narrowedconfiguration;

FIGS. 21 and 22 are views similar to FIGS. 19 and 20 of the apparatus ofFIG. 19 in a widened configuration;

FIGS. 23 to 25 are partially cross-sectional, side views of anotherapparatus according to the invention, in use;

FIG. 26 is an isometric view of another apparatus according to theinvention and a surgical device; and

FIG. 27 is an end view of the apparatus and the surgical device of FIG.26.

DETAILED DESCRIPTION

Referring to the drawings, and initially to FIGS. 1 to 11 thereof, thereis illustrated an apparatus 1 according to the invention. The apparatus1 is suitable for inserting a surgical device, such as a wound retractordevice 2, at least partially through a wound opening 3. The apparatus 1comprises a conveying device 4 and a separate holder element 5. Theholder element 5 is formed separately from the conveying device 4.

In this case the wound retractor device 2 comprises a distal ring 52 forlocation internally of the wound opening 3 to anchor the wound retractordevice 2 in position retracting the wound opening 3.

The conveying device 4 is insertable at least partially through thewound opening 3 to convey the wound retractor device 2 at leastpartially through the wound opening 3. The conveying device 4 comprisesa hook element 6 for engaging the wound retractor device 2. The hookelement 6 is non-circular in cross-section.

A bladeless tip 7 is provided mounted to the distal end of the conveyingdevice 4 to create the wound opening 3 by forcing tissue apart. The tip7 has a flattened, non-symmetrical shape in cross-section. In this casethe major axis of the tip 7 is arranged at 90° to the major axis of thehook element 6.

FIG. 1 illustrates the bladeless hook introducer 4 with a soft rubberskin deflector 8. The soft rubber skin deflector 8 prevents skin layerssnagging on the hook 6 during introduction of the distal ring 52 of thewound retractor device 2 (FIG. 2).

The holder element 5 is provided in this case in the form of an annularflange arranged concentrically around the conveying device 4. The holderelement 5 extends radially outwardly from the conveying device 4. Theholder element 5 may be employed to hold at least part of the woundretractor device 2 in a low-profile configuration.

The holder element 5 is slidable relative to the conveying device 4along the conveying device 4 between a holding configuration in which atleast part of the wound retractor device 2 is held in the low-profileconfiguration (FIG. 3), and a release configuration in which the woundretractor device 2 is released (FIGS. 5 and 6). As the conveying device4 is inserted through the wound opening 3, the holder element 5 engageswith the external surface of the tissue (FIG. 4). In this manner theholder element 5 is moved from the holding configuration to the releaseconfiguration. The holder element 5 remains detached from the conveyingdevice 4 in both the holding configuration and in the releaseconfiguration.

The holder element 5 may be disassembled from the conveying device 4after the wound retractor device 2 has been conveyed through the woundopening 3. The conveying device 4 may be withdrawn through the centralopening of the annular holder element 5.

After insertion of the wound retractor device 2, the conveying device 4is removed from the wound opening 3, and the holder element 5 remains inposition externally of the wound opening 3 (FIG. 8).

In FIG. 5, the ring 52 has been compressed passing through thecompression washer 5 which results in more streamlined entry.

In FIG. 7, in order to release the distal ring 52 from the hook 6 andthe soft rubber skin deflector 8, the user rotates the bladeless hookintroducer 4 within the incision 3. The soft rubber skin deflector 8deforms easily to release the distal ring 52. The user then removes theintroducer 4.

FIG. 8 illustrates the compression washer 5, and the distal ring 52deployed.

The holder element 5 may be arranged concentrically around the conveyingdevice 4 before the conveying device 4 approaches the tissue.Alternatively the holder element 5 may be placed resting against thetissue before the conveying device 4 approaches the tissue (FIGS. 10 and11). The conveying device 4 then passes through the central opening inthe holder element 5 to compress the wound retractor device 2 to thelow-profile configuration.

In the embodiment of FIGS. 12 and 13, a circumferential discontinuity 10is provided in the holder element 5. In this case the circumferentialdiscontinuity 10 is provided in the form of a cut through the annularflange 5. The discontinuity 10 enables the holder element 5 to be movedradially away from the conveying device 4 from the holding configuration(FIG. 12) to the release configuration (FIG. 13). In this manner theholder element 5 may be removed from being concentrically around theconveying device 4 in a fast, convenient manner.

The circumferential discontinuity 10 enables the holder element 5 to bedisassembled from the wound retractor device 2 after the distal ring 52of the wound retractor device 2 has been inserted through the woundopening 3.

In FIG. 12 the compression washer 5 has the split 10 in it to facilitateremoval from around the introducer shaft 4.

FIG. 13 illustrates the compression washer 5 removed as a result of thesplit 10, and the distal ring 52 inside the abdomen.

In the embodiment of FIGS. 14 to 16 the holder element 20 is provided inthe form of a tubular element. The tubular element 20 has acircumferential discontinuity 21 in the form of an opening extendingalong the tubular element 20.

FIG. 14 illustrates the compression clip 20 with the gap 21 for removal.The clip 20 may be preloaded. The clip 20 may be hinged.

FIG. 15 illustrates an alternative in which the compression clip 20 isleft on the abdomen and the introducer 4 is passed through it,compressing the distal ring 52.

FIG. 16 illustrates that the split 21 allows the compression clip 20 tobe removed once the distal ring 52 has passed through the incision 3.

In the embodiment of FIGS. 16( a) to 16(d) the holder element 30 isprovided in the form of a tubular element. The tubular element 30 has aproximal funnel part 31 which tapers radially inwardly distally. Thefunnel part 31 assists collapse of the wound retractor device 2 from therelease configuration to the low-profile configuration (FIGS. 16( c) and16(d)).

The tubular element 30 has a distal flange part 32.

As illustrated in FIG. 16( b), the tubular element 30 has an ellipticalshape in cross-section.

FIG. 16( a) illustrates the tapered lead-in 31 to promote compression ofthe distal ring 52, and the flange 32 for stability. FIG. 16( b)illustrates the elliptical cross-section.

FIG. 16( c) illustrates the clip 30 placed on a table top, and theintroducer 4 and the distal ring 52 being pushed down into the clip 30to load for the surgeon.

FIG. 16( d) illustrates the distal ring 52 streamlined by the clip 30.The surgeon can then pass the introducer 4 and the ring 52 easilythrough the abdominal wall.

In the embodiment of FIGS. 16( d)(i) to 16(d)(iii), the apparatus 1 andthe wound retractor device 2 are housed in a pack 100. The conveyingdevice 4 is slidable in the pack 100 relative to the tubular element 30from a storage configuration in which the distal ring 52 of the woundretractor device 2 is released (FIGS. 16( d)(i) and 16(d)(ii)), to theholding configuration in which the distal ring 52 is held in thelow-profile configuration (FIG. 16( d)(iii)).

FIG. 16( d)(i) illustrates the packaging 100 with packaging support 101,the clip 30, the wound retractor device 2, the hook introducer 4, andthe distal ring 52. The wound retractor device 2 and the introducer 4are in the packaging 100. The user pushes the introducer 4 down untilthe distal ring 52 is compressed in the clip 30.

FIG. 16( d)(ii) illustrates a rear view of the clip 30 with the funneltop 31.

In FIG. 16( d)(iii) the introducer 4 is pushed until the distal ring 52is compressed in the clip 30. The funnel 31 aids compression.

In the embodiment of FIGS. 16( e) to 16(g) the holder element 40 isprovided in the form of a tubular element. The tubular element 40 has afunnel part 41 which tapers radially inwardly distally. The funnel part41 extends from the proximal end of the tubular element 40 to the distalflange part 42.

FIG. 16( f) illustrates that the taper 41 extends over the entire heightof the streamlining clip 40.

In the embodiment of FIG. 16( h) the holder element 50 is provided inthe form of a tubular element. The tubular element 50 is attached to thewound retractor device 2. In this case the tubular element 50 isattached to a release ribbon 51 of the wound retractor device 2. Therelease ribbon 51 may be employed to release the distal ring 52 of thewound retractor device 2 from a retracting configuration when it isdesired to remove the distal ring 52 from the wound opening 3.

FIG. 16( h) illustrates the restraining sleeve 50, the ribbon 51, andthe wound retractor device 2.

In the embodiment of FIGS. 16( i) to 16(n) the holder element 60 isprovided in the form of a tubular element. In this case the tubularelement 60 is not arranged concentrically around the conveying device 4in the holding configuration. Instead the tubular element 60 is arrangedradially offset from the conveying device 4 in the holding configuration(FIG. 16( k)). The tubular element 60 and the conveying device 4 arelocated in a side-by-side arrangement (FIG. 16( k)). The tubular element60 is slidable relative to the conveying device 4 from the holdingconfiguration to the release configuration (FIGS. 16( l) to 16(n)).

FIGS. 16( i) to 16(n) illustrate the restraining clip 60 for keeping thedistal ‘O’-ring 52 compressed while being inserted.

FIG. 16( i) illustrates the restraining clip 60, the ribbon 51 attachedto the clip 60, and the ‘O’ ring 52 on the hook 6. FIG. 16( j)illustrates the clip 60 sliding up over the ring 52 only. FIG. 16( k)illustrates the ring 52 compressed and the clip 60 sliding off.

FIG. 16( m) illustrates that as the introducer 4 is pushed into theskin, the clip 60 slides off FIG. 16( n) illustrates the clip 60attached to the ribbon 51.

In the embodiment of FIGS. 16( o) to 16(t) the holder element 70 isprovided in the form of a tubular element. The tubular element 70 hastwo openings 71 in the side walls of the tubular element 70 (FIG. 16(o)). Each opening 71 is provided in the form of an elongate slot.

The tubular element 70 is slidable relative to the conveying device 4from a storage configuration in which the distal ring 52 of the woundretractor device 2 is released (FIG. 16( s)) to the holdingconfiguration (FIG. 16( t)), and from the holding configuration (FIG.16( t)) to the release configuration.

As illustrated in FIG. 16( p), in the storage configuration the tubularelement 70 is arranged concentrically around the distal ring 52, withthe distal ring 52 extending through the openings 71.

FIG. 16( o) illustrates the side slots 71 which allow the distal ring 52to be pre-loaded in this streamlining clip 70. The slots 71 ensure thatthe ring 52 is not compressed. Thus the shelf-life is enhanced.

FIG. 16( p) illustrates the distal ring 52 loaded in the streamliningclip 70. The ring 52 is unrestrained due to the side slots 71.

FIG. 16( q) illustrates the distal ring 52 attached onto the hook 6. Thestreamlining clip 70 with the side slots 71 is then placed over thedistal ring 52. This step may take place during manufacture. The surgeonwould therefore not have to load the clip 70 onto the ring 52.

FIG. 16( r) illustrates the bladeless hook introducer 4, thestreamlining clip 70 with the side slots 71 and the distal ring 52. FIG.16( s) illustrates the base of the streamlining clip 70 engaging theskin, and the incision 3.

FIG. 16( t) illustrates that as the hook introducer 4 advances throughthe abdominal wall, the distal ring 52 becomes compressed by thestreamlining clip 70. The ring 52 therefore passes through the woundopening 3 more easily.

It will be appreciated that there are a variety of different means forholding the wound retractor device 2 in the low-profile configuration.For example the user could simply squeeze the wound retractor device 2into the low-profile configuration using the user's fingers (FIG. 17).FIG. 17 illustrates the distal ring 52 being compressed manually.

It will also be appreciated that the major axis of the tip 7 may bealigned with the major axis of the hook element 6, as illustrated inFIG. 18. FIG. 18 illustrates the alternative orientation of the cuttingtip 7.

In the embodiment of FIGS. 19 to 22 the bladeless tip 80 is mounted tothe distal end of the conveying device 4 to create the wound opening 3by forcing tissue apart.

The tip 80 comprises a main body portion 81 and two side wing elements82. Each of the wing elements 82 is movable relative to the main bodyportion 81 between a narrowed configuration (FIG. 19) and a widenedconfiguration (FIG. 21). In this manner the width of the distal tip 80may be adjusted. By adjusting the width of the distal tip 80, the sizeof the wound opening 3 created may be varied to suit particularrequirements.

The tip 80 has a flattened, non-symmetrical shape in cross-section(FIGS. 20 and 22). The wing elements 82 are movable relative to the mainbody portion 81 in a direction parallel to the major axis of the tip 80.

An actuator handle 83 is provided for user control of adjustment of thewidth of the tip 80.

FIGS. 19 and 20 illustrate the adjustable cutting wings 82, and thethumbswitch 83 for the adjustable cutting wings 82. FIGS. 21 and 22illustrate the thumbswitch 83 down, and the adjustable cutting wings 82fanned out to create a larger incision.

In the embodiment of FIGS. 23 to 25 the apparatus 90 comprises a handle91 to facilitate a user gripping the apparatus 90.

A lumen 92 extends through the conveying device 4 from the proximal endof the conveying device 4 towards the distal tip 93. The lumen 92extends parallel to and in-line with the longitudinal axis A-A of theconveying device 4. A laparoscope 93 may be extended through the lumen92.

As illustrated in FIG. 23; the apparatus 90 is asymmetrical about thelongitudinal axis A-A of the conveying device 4. In particular thehandle 91 is radially offset from the longitudinal axis A-A of theconveying device 4. Because the handle 91 is radially offset from thelongitudinal axis A-A, this provides for ease of passage of thelaparoscope 93 through the lumen 92.

FIGS. 23 to 25 illustrate the handle 91 which allows more comfortableuse with the laparoscope 93.

In FIGS. 26 and 27 there is illustrated another apparatus 200 accordingto the invention, which is similar to the apparatus of FIG. 18, andsimilar elements in FIGS. 26 and 27 are assigned the same referencenumerals.

In this case the conveying device 4 comprises a resilient flap 201 whichextends across the full width of a passageway 202 between the concaveportion of the hook element 6 and externally of the conveying device 4.The passageway 202 facilitates location of the distal ring 52 inengagement with the hook element 6. She flap 201 may be used toselectively obstruct the full width of the passageway 202 to retain thedistal ring 52 of the wound retractor device 2 in engagement with thehook element 6.

The flap 201 overlaps the passageway 202. In particular the distal end205 of the flap 201 is located distally of the distal side 203 of thepassageway 202, and the proximal end 206 of the flap 201 is locatedproximally of the proximal side 204 of the passageway 202.

The flap 201 is movable between an obstructing configuration in whichthe flap 201 extends across to obstruct the full width of the passageway202 and a passage configuration in which the flap 201 is bent back tofacilitate passage of the distal ring 52 of the wound retractor device 2through the passageway 202 into and out of the concave portion of thehook element 6. In the obstructing configuration, the flap 201 retainsthe distal ring 52 in engagement with the hook element 6 duringinsertion of the wound retractor device 2 through the wound opening 3.The resilient nature of the flap 201 biases the flap 201 towards theobstructing configuration.

FIGS. 26 and 27 illustrate the hook introducer 200 with the hookprotecting flap 201. FIG. 26 illustrates the retracting sleeve 2, thedistal ring 52, the bladeless dissecting tip 7, and the flap 201 whichcovers the hook 6 to prevent skin layers getting snagged under the hooktip 204 or the ring 52. FIG. 27 illustrates the retracting sleeve 2, thedistal ring 52, the shaft 4, the hook 6, and the flap 201 to cover thehook 6.

The invention is not limited to the embodiments hereinbefore described,with reference to the accompanying drawings, which may be varied inconstruction and detail.

1-73. (canceled)
 74. An apparatus for inserting a surgical device atleast partially through a wound opening, the apparatus comprising:— aconveying device insertable at least partially through a wound openingto convey a surgical device at least partially through the woundopening; and a holder element for holding at least part of the surgicaldevice in a low-profile configuration.
 75. An apparatus as claimed inclaim 74 wherein the holder element is configured to be disassembledfrom the conveying device.
 76. An apparatus as claimed in claim 75wherein the holder element is configured to be disassembled from theconveying device after conveying of a surgical device at least partiallythrough a wound opening.
 77. An apparatus as claimed in claim 74 whereinthe holder element is configured to be disassembled from a surgicaldevice.
 78. An apparatus as claimed in claim 74 wherein the holderelement comprises a circumferential discontinuity.
 79. An apparatus asclaimed in claim 74 wherein the holder element is formed separately fromthe conveying device.
 80. An apparatus as claimed in claim 74 whereinthe holder element is movable relative to the conveying device between aholding configuration in which at least part of a surgical device isheld in a low-profile configuration, and a release configuration inwhich the surgical device is released.
 81. An apparatus as claimed inclaim 80 wherein the holder element is slidable relative to theconveying device between the holding configuration and the releaseconfiguration.
 82. An apparatus as claimed in claim 81 wherein theholder element is slidable relative to the conveying device along theconveying device.
 83. An apparatus as claimed in claim 80 wherein theholder element is engagable with an external surface of tissue uponinsertion of the conveying device at least partially through a woundopening to move the holder element from the holding configuration to therelease configuration.
 84. An apparatus as claimed in claim 80 whereinthe holder element is movable radially relative to the conveying devicebetween the holding configuration and the release configuration.
 85. Anapparatus as claimed in claim 74 wherein the holder element isconfigured to be arranged concentrically around the conveying device atleast in the holding configuration.
 86. An apparatus as claimed in claim85 wherein the holder element is removable from being concentricallyaround the conveying device.
 87. An apparatus as claimed in claim 74wherein the holder element is configured to be arranged radially offsetfrom the conveying device at least in the holding configuration.
 88. Anapparatus as claimed in claim 80 wherein the holder element is movablerelative to the conveying device between a storage configuration inwhich at least part of a surgical device is released, and the holdingconfiguration.
 89. An apparatus as claimed in claim 88 wherein theholder element is slidable relative to the conveying device between thestorage configuration and the holding configuration.
 90. An apparatus asclaimed in claim 88 wherein the holder element is configured to bearranged concentrically around at least part of a surgical device in thestorage configuration.
 91. An apparatus as claimed in claim 88 whereinthe holder element comprises one or more openings through which part ofa surgical device may extend in the storage configuration.
 92. Anapparatus as claimed in claim 74 wherein the holder element isconfigured to extend radially outwardly from the conveying device. 93.An apparatus as claimed in claim 74 wherein the holder element comprisesan annular flange element.
 94. An apparatus as claimed in claim 74wherein the holder element comprises a tubular element.
 95. An apparatusas claimed in claim 74 wherein the holder element is configured toassist collapse of at least part of a surgical device from a releaseconfiguration to a low-profile configuration.
 96. An apparatus asclaimed in claim 95 wherein at least part of the holder elementcomprises a funnel part.
 97. An apparatus as claimed in claim 95 whereinat least part of the holder element is tapered.
 98. An apparatus asclaimed in claim 97 wherein at least part of the holder element tapersradially inwardly distally.
 99. An apparatus as claimed in claim 74wherein the holder element is non-circular in cross-section.
 100. Anapparatus as claimed in claim 99 wherein the holder element iselliptical in cross-section.
 101. An apparatus as claimed in claim 74wherein the holder element is configured to be attached to a surgicaldevice.
 102. An apparatus as claimed in claim 74 wherein the conveyingdevice comprises a retaining element to retain a surgical device inengagement with the conveying device, and a passageway to facilitatelocation of the surgical device in engagement with the conveying device,the retaining element being configured to selectively obstruct the fullwidth of the passageway.
 103. An apparatus as claimed in claim 102wherein the proximal end of the retaining element is located proximallyof the proximal side of the passageway.
 104. An apparatus as claimed inclaim 102 wherein the distal end of the retaining element is locateddistally of the distal side of the passageway.
 105. An apparatus asclaimed in claim 102 wherein the retaining element overlaps thepassageway.
 106. An apparatus as claimed in claim 74 wherein theconveying device comprises a hook element to engage a surgical device.107. An apparatus as claimed in claim 106 wherein the hook element isnon-symmetrical in cross-section.
 108. An apparatus as claimed in claim106 wherein the hook element is non-circular in cross-section.
 109. Anapparatus as claimed in claim 74 wherein the apparatus comprises anopening device to create a wound opening.
 110. An apparatus as claimedin claim 109 wherein the opening device is configured to create a woundopening by forcing tissue apart.
 111. An apparatus as claimed in claim109 wherein the opening device is mounted to the conveying device. 112.An apparatus as claimed in claim 109 wherein the opening device isnon-symmetrical in cross-section.
 113. An apparatus as claimed in claim109 wherein the major axis of the opening device is substantiallyaligned with the major axis of the hook element.
 114. A surgicalassembly comprising:— a surgical device; and an apparatus as claimed inclaim 74 for inserting the surgical device at least partially through awound opening.
 115. An opening device to create a wound opening, thesize of at least part of the opening device being adjustable to vary thesize of the wound opening created.
 116. An apparatus for inserting asurgical device at least partially through a wound opening, theapparatus comprising:— a conveying device insertable at least partiallythrough a wound opening to convey a surgical device at least partiallythrough the wound opening; and an opening device as claimed in claim115.
 117. An apparatus for inserting a surgical device at leastpartially through a wound opening, the apparatus comprising:— aconveying device insertable at least partially through a wound openingto convey a surgical device at least partially through the woundopening; and a handle for gripping the apparatus; the handle beingradially offset from the longitudinal axis of the conveying device. 118)A method of inserting a surgical device at least partially through awound opening, the method comprising the steps of:— providing a surgicaldevice; creating a wound opening; holding at least part of the surgicaldevice in a low-profile configuration; and conveying the surgical deviceat least partially through the wound opening.